Clinical Trials associated with The Seventh Affiliated Hospital of Sun Yat sen University (Shenzhen)
NCT07872254
/ Not yet recruitingNot ApplicableIIT
Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients: a Feasibility Study
Advanced cancer is a leading cause of death worldwide and in China. Cancer patients often face reduced independence and self-care abilities, which may lead to psychological disturbances such as helplessness, hopelessness, or meaninglessness. This combination of these negative emotions is called demoralization. Approximately 35.8% of cancer patients experience demoralization, with higher rates in terminal stages. If unrecognized or untreated, it can increase physical and mental symptom burden, reduce quality of life, and even lead to suicide. To date, no professional bodies currently recommend treatment guidelines. One meta-analysis suggests that psychological interventions could significantly reduce demoralization; however, the requirement for in-person attendance may create accessibility challenges, potentially reducing the flexibility and acceptability of psychological interventions for cancer patients undergoing chemotherapy or receiving treatment at home. To address the identified literature gap, a co-designed digital psychological intervention was developed, and this study will evaluate its feasibility. A convenience sample of 30 advanced cancer patients meeting the inclusion criteria will be recruited from the oncology ward of a hospital in Shenzhen. Participants will receive five 30-45 minute sessions of a co-designed, digitally-enabled positive psychological intervention, delivered weekly over five weeks. A trained researcher will introduce the intervention before discharge and deliver it through a WeChat Mini Program in the patients' homes. The primary outcome will be feasibility (time to complete recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, and acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on demoralization, suicidal ideation, and quality of life of advanced cancer patients at baseline (after collecting demographic information and written consent forms) and post-intervention. A separate researcher will conduct a descriptive qualitative evaluation with 12 participants to explore their experience of the intervention. Qualitative data will be audio-taped, transcribed verbatim, and analyzed using NVivo 14 through thematic analysis. Quantitative data will be entered into SPSS version 29.0. Descriptive statistics will be used to summarize the profiles of participants and outcomes.
The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3
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